Senior Specialist, Engineering (Deviation Management)

Job Description

Our Engineers support internal and external manufacturing operations remaining operational, continuously improve and innovate. With our extensive range of facilities and environments, our Engineers have opportunities across many diverse areas including Biological, Chemical, Automation, Capital Projects, Maintenance, Safety, Process Development, Technical Services, Utilities and Validation.  

We are seeking a Growth and Improvement minded individual to lead a Deviation Management team within Polysaccharide Vaccines that can help drive our Strategic Operating Priorities.

• Invent | Pursue the Most Promising Internal and External Science to Address Significant Unmet Medical Needs
• Execute | Prioritize Resources Behind Our Key Growth Drivers (Oncology, Vaccines, Select Specialty Areas, Animal Health) While Optimizing Our Base Business)
• Adapt | Develop Our People, Culture and Business Model to Evolve with a Dynamic Landscape
• Diverse Talent | We are committed to providing an inclusive and welcoming environment with supporting leadership behaviors because having a high performing, engaged workforce is critical to our ability to deliver innovative solutions to patients and customers around the world
• Values and Standards | Our Steadfast Commitment to Our Values and Standards will Continue to Guide Us as We Take on New Challenges and Will Always be Fundamental to Our Success – They are a Competitive Advantage for Us

Summary:

As part of our Manufacturing Division, Polysaccharide Vaccines Technical Operations at West Point is seeking a highly motivated leader to partner with the Operations, Quality Operations, and Regulatory groups by leading a deviation management team to meet targeted supply and compliance initiatives. This position will require development of technical expertise of corresponding IPT operations and mentorship/development of more junior members of the deviation management team. Polysaccharide Vaccines includes fermentation processing, vaccine purification, media preparation, bulk formulation, sterile filtration, and manufacture of conjugate vaccine processes.

Key Responsibilities:

• Leads/manages a deviation management team of up to five investigators and provides mentorship/development of more junior team members and contractors.
• Conducts more complex investigations and drives to appropriate root causes and corrective actions.
• Collaborates with IPT Operations, Technical Operations, and Quality leadership to identify deviation trends and establish continuous improvement opportunities to reduce potential deviations.
• Coordinates and prioritizes deviations based on investigator, batch ROT, and supply.
• Reviews deviations with regulatory agencies and provides health authority reporting as required.
• Has ability to examine an issue from diverse perspectives (safety, compliance, automation, equipment, process, and people) in order to best understand and resolve the root cause.
• Assures consistent application of standardized work, engineering and process tools.
• Authors and updates technical and manufacturing documents necessary for investigations, process design/definition, engineering studies, process demonstrations, change control and validation.
• Provides technical guidance to staff, colleagues or customers as well as anticipates and interprets the customer needs to identify solutions.  Includes approval of technical documentation including investigations, protocols, reports, etc. as required.

Education:

• Bachelor's Degree in Chemical Engineering, Biological Sciences or other related science or engineering field with four (4) years relevant work experience, including direct support of development or manufacturing of biologics or sterile products.

Required Experience and Skills:

• Demonstrated leadership and ability to drive results
• Strong communication, collaboration skills and ability to drive accountability
• Strong problem-solving skillset
• Experience authoring investigations

Preferred Experience and Skills:

• Vaccine manufacturing
• Participation in regulatory inspections
• Prior management experience

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Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

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